ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL

ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL is an FDA 510(k)-cleared medical device (K132399) manufactured by Elitechgroup. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 2014. Regulation: 8.